A recent study published in The American Journal of Obstetrics and Gynecology indicated that while the Posterior IVS Tunneller transvaginal mesh delivery system was the first of its kind, and was a viable option for pelvic organ prolapse repair, a range of similar systems were released soon after without being subjected to clinical trials. All FDA approval for these new designs was sourced from post-market clinical trials. This means that the device was circulating in the American market prior to having its safety fully evaluated.
Here is an FDA bulletin regarding the danger of transvaginal mesh, published in 2011.
Upon researching the post-market clinical trials of the Posterior IVS Tunneller, researchers found that the results indicated poor success rates as well as a high number of complications due to the use of this system.
This study published in The American Journal of Obstetrics and Gynecology indicated that while often times these mesh delivery systems were considered to be successful, the adverse effects associated with TVM were often unnoticed until more than a year after surgery. These particular finding have in fact been corroborated by a plethora of other contemporary researchers. To find out more about unnoticed TVM side effects, follow the link above.
Complications were often not detected until swelling around the mesh reached the point beyond introitus and often, no pain is reported with these complications.
Our vaginal mesh lawyers may be able to help you or a loved one with filing a vaginal mesh lawsuit if postoperative complications have occurred with the Posterior IVS Tunneller or other such transvaginal mesh delivery systems.
For a free consultation, do not hesitate to call or write at (855) 452-5529 or email@example.com. We have the experience, resources, and skills required to win the justice you deserve. Also, our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.